NCT07043686

Brief Summary

The study evaluates the effect and safety of Cerebrolysin administered during early rehabilitation in patients with moderate neurological impairment after acute ischemic stroke, conducted at the Department of Vascular Neurology and Intensive Neurological Therapy, UMC Ljubljana.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
17mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Jun 2025Oct 2027

Study Start

First participant enrolled

June 13, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 29, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2027

Last Updated

July 9, 2025

Status Verified

July 1, 2025

Enrollment Period

2.1 years

First QC Date

June 20, 2025

Last Update Submit

July 3, 2025

Conditions

Ischemic Stroke, AcuteRehabilitation OutcomeCerebrolysin

Keywords

CerebrolysinAcute Ischemic StrokeNeuroplasticityNeurorehabilitationAction Research Arm TestSlovenia

Outcome Measures

Primary Outcomes (1)

  • 90-day Action Research Arm Test (ARAT) Score change

    A standardized test after stroke to measure the function of the upper limb. Range of scores: 0-57, with higher scores meaning a better outcome.

    90 days post-stroke

Secondary Outcomes (5)

  • National Institute of Health Stroke Scale (NIHSS) at discharge and 90 days

    90 days

  • Modified Rankin Score (mRS) at day 90

    90 days

  • Extended Barthel index (EBI) 90 days post-stroke

    90 days

  • The De Morton Mobility Index (DEMMI) Score 90 days

    90 days

  • Montreal Cognitive Assessment (MoCA) 90 days

    90 days

Study Arms (2)

Arm 1: Cerebrolysin Group

EXPERIMENTAL

The patients in Arm 1 will be treated with cerebrolysin and standard treatment.

Drug: Cerebrolysin treatmentOther: Standard treatment (including neurorehabilitation) of acute ischemic stroke

Arm 2: Standard treatment only Group

OTHER

The patients in Arm 2 will receive standard treatment only.

Other: Standard treatment (including neurorehabilitation) of acute ischemic stroke

Interventions

Cerebrolysin treatmentDRUG

The patients will receive Cerebrolysin treatment, 10 days consecutively, 30 ml/day, intravenous infusion diluted up to 100 ml of 0.9% saline in 15 minutes.

Arm 1: Cerebrolysin Group
Standard treatment (including neurorehabilitation) of acute ischemic strokeOTHER

"Standard treatment" entails acute ischemic stroke reperfusion treatment according to international guidelines and local policies, instituting secondary preventive treatment, a proper management of stroke risk factors and neurorehabilitation according to patient's needs: locomotor physiotherapy, occupation therapy, speech therapy, and neuropsychological assessment.

Arm 1: Cerebrolysin GroupArm 2: Standard treatment only Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being able to perform ARAT test Signed informed consent
  • Both sexes, age not specified
  • Acute ischemic stroke confirmed by imaging
  • NIHSS score 6-12
  • No prior stroke or disability (mRS 0 before stroke)

You may not qualify if:

  • Not being able to perform ARAT test
  • Previous stroke or disability (mRS \> 0)
  • The patient unable to understand instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Ljubljana - Department of Vascular Neurology and Intensive Neurological Therapy (KOVNINT)

Ljubljana, 1000, Slovenia

RECRUITING

Related Publications (1)

  • van den Brule FA, Castronovo V, Menard S, Giavazzi R, Marzola M, Belotti D, Taraboletti G. Expression of the 67 kD laminin receptor in human ovarian carcinomas as defined by a monoclonal antibody, MLuC5. Eur J Cancer. 1996 Aug;32A(9):1598-602. doi: 10.1016/0959-8049(96)00119-0.

    PMID: 8911124BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Matija Zupan, MD, PhD

    University Medical Centre Ljubljana

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matija Zupan, MD, PhD

CONTACT

0038615229581matija.zupan@kclj.si

Marjan Zaletel, MD, PhD

CONTACT

0038615227115marjan.zaletel@kclj.si

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
neurologist, MD, PhD

Study Record Dates

First Submitted

June 20, 2025

First Posted

June 29, 2025

Study Start

June 13, 2025

Primary Completion (Estimated)

July 15, 2027

Study Completion (Estimated)

October 15, 2027

Last Updated

July 9, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

De-identified clinical outcomes data for academic purposes

Locations

SL(1)